UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034013
Receipt number R000038754
Scientific Title Human monitor test of Spanish extra virgin olive oil derived from Picual species
Date of disclosure of the study information 2018/09/03
Last modified on 2020/09/12 10:42:21

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Basic information

Public title

Human monitor test of Spanish extra virgin olive oil derived from Picual species

Acronym

Human monitor test of Spanish extra virgin olive oil derived from Picual species

Scientific Title

Human monitor test of Spanish extra virgin olive oil derived from Picual species

Scientific Title:Acronym

Human monitor test of Spanish extra virgin olive oil derived from Picual species

Region

Japan


Condition

Condition

Healthy subjects

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study aims to examine the influence on blood properties by continuously ingesting test foods for 4 weeks for healthy Japanese males and females ages 20 to 65 years old.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Blood BDNF

Key secondary outcomes

Serum lipids


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

4-week intake of the test food
Wash out
4-week intake of the placebo

Interventions/Control_2

4-week intake of the placebo
Wash out
4-week intake of the test food

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

65 years-old >

Gender

Male and Female

Key inclusion criteria

1)Japanese males and females aged 20 to 65 years when informed concent.
2)Subjects who can continuously drink test for 4 weeks.
3)Subjects who got an explanation about the purpose and content of the research and obtained written consent.

Key exclusion criteria

1)Subjects with or who have a history of diseases such as diabetes mellitus, liver disease, kidney disease, or heart disease.
2)Currently, exercise therapy and diet therapy are performed under the supervision of a physician.
3)Subjects with diseases requiring continuous medication
4)Subjects with a history of drug or food allergy
5)Subjects who consume olive oil continuously
6)Subjects who have a history of cholelithiasis
7)Subjects who have participated in other human clinical studies within the past 3 months or are expected to participate in other human clinical studies during the study period.
8)Other than the above, the principal investigator judged the subject to be inappropriate.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Takayuki
Middle name
Last name Nakano

Organization

Kagoshima Immaculate Heart University

Division name

Department of Health and Nutrition, Faculty of Nursing and Nutrition

Zip code

8900045

Address

2365 Amatatsu, Satsuma-sendai, Kagoshima, 895-0011, Japan

TEL

0996-23-5311

Email

nakano@jundai.k-junshin.ac.jp


Public contact

Name of contact person

1st name Takayuki
Middle name
Last name Nakano

Organization

Kagoshima Immaculate Heart University

Division name

Department of Health and Nutrition, Faculty of Nursing and Nutrition

Zip code

8900045

Address

2365 Amatatsu, Satsuma-sendai, Kagoshima, 895-0011, Japan

TEL

0996-23-5311

Homepage URL


Email

nakano@jundai.k-junshin.ac.jp


Sponsor or person

Institute

Kagoshima Immaculate Heart University

Institute

Department

Personal name



Funding Source

Organization

Hioki city

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kagoshima Immaculate Heart University

Address

2365 Amatatsu, Satsuma-sendai, Kagoshima, 895-0011, Japan

Tel

0996235311

Email

kaz@jundai.k-junshin.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2018 Year 09 Month 03 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2018 Year 07 Month 24 Day

Date of IRB

2018 Year 07 Month 24 Day

Anticipated trial start date

2018 Year 09 Month 05 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 09 Month 03 Day

Last modified on

2020 Year 09 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038754


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name